Instructions Maltofer chewable tablets 100 mg blister No. 30
Composition
active ingredient: 1 tablet contains 357 mg of iron (III) hydroxide polymaltozate, which is equivalent to 100 mg of iron;
excipients: microcrystalline cellulose, cocoa powder, sodium cyclamate, polyethylene glycol 6000, talc, vanillin, dextrates, chocolate flavoring.
Dosage form
Chewable tablets.
Main physicochemical properties: brown tablets with white inclusions and a score.
Pharmacotherapeutic group
Antianemic agents. Iron (III) preparations for oral administration. ATC code B03A B05.
Pharmacological properties
Pharmacodynamics
The surface of the polynuclear iron(III) hydroxide base in the iron hydroxide polymaltose complex is surrounded by non-covalently bound polymaltose molecules, which results in an average total molecular weight of about 50 kDa. The structure of the polynuclear iron(III) hydroxide base in the iron–polymaltose complex is similar to that of ferritin, a physiological protein depot of iron. The iron hydroxide polymaltose complex is stable and does not release iron in large quantities under normal physiological conditions. Due to its size, the diffusion of the iron hydroxide polymaltose complex across the mucosa is approximately 40 times less than the diffusion of most water-soluble iron(II) salts contained in aqueous solutions as the hexaaqua-iron(II) complex. Iron from the polymaltose complex is absorbed in the intestine by active mechanisms. Absorbed iron binds to transferrin and is used for hemoglobin synthesis in the bone marrow or is deposited mainly in the liver in a ferritin-bound form.
Clinical efficacy.
The effectiveness of Maltofer in normalizing hemoglobin levels and restoring iron stores compared to placebo or similar iron preparations in various dosage forms has been demonstrated in many clinical studies conducted in infants, children, adolescents and adults. Both solid and liquid dosage forms of iron polymaltose complex were used in these studies. The primary goal of oral iron replacement therapy is to maintain the body's own iron stores within normal limits (for the prevention of iron deficiency, for example, in cases of increased need), replenish iron stores or correct existing iron deficiency anemia.
Clinical studies conducted in adults.
A total of 11 controlled clinical trials of monotherapy with iron (III) hydroxide polymaltose complex compared with placebo and/or oral iron (II) preparations were conducted.
Over 900 patients were enrolled in these studies, approximately 500 of whom received monotherapy with polymaltose iron(III) hydroxide complex. In the study population, no significant difference was demonstrated in hematological parameters and iron parameters (hemoglobin (Hb), mean corpuscular volume (MCV), serum ferritin) at baseline. Oral replacement therapy with polymaltose iron(III) hydroxide complex at a dose of 100–200 mg iron/day for several weeks, up to a maximum of six months, provided a clinically significant increase in iron and hematological parameters at the end of therapy compared with baseline. The improvement in hematological parameters (Hb, MCV, serum ferritin) after a 12-week course of therapy with polymaltose iron(III) complex was comparable to that with ferrous sulfate.
The efficacy of iron polymaltose complex in the treatment of adult patients with iron deficiency anemia was compared with that of ferrous sulfate (II) in a meta-analysis of six prospective randomized clinical trials. The total number of patients included in the meta-analysis was 557; 319 of them received iron polymaltose complex hydroxide and 238 patients received ferrous sulfate (II). The mean total hemoglobin at baseline was 10.35 ± 0.92 g/dL (in the iron polymaltose complex group) and 10.20 ± 0.93 g/dL (in the ferrous sulfate group). After a treatment period of a mean duration of 8–13 weeks with equivalent doses, the mean hemoglobin level was 12.13 ± 1.19 g/dL (in the iron polymaltose complex group) and 11.94 ± 1.84 g/dL (in the ferrous sulfate (II) group), p = 0.93, the increase in hemoglobin level was greater after longer use for both drugs.
Clinical trials involving children and adolescents.
The use of Maltofer in the treatment of children and adolescents (up to 18 years of age) has been studied in numerous clinical trials involving over 1000 patients. The effectiveness of Maltofer in improving iron levels has been confirmed in comparison with placebo or other iron preparations.
Absorption and distribution. A study with radiolabeled polymaltose ferric hydroxide complex showed a good correlation between iron absorption and iron accumulation in hemoglobin. There is a correlation between the degree of iron deficiency and the relative amount of iron absorbed (the higher the level of iron deficiency, the better the absorption). It was found that food, unlike iron (II) salts, does not negatively affect the bioavailability of iron from Maltofer: a clinical study demonstrated that the bioavailability of iron significantly increases when taken with food, while three other studies demonstrated only a positive trend, and not a significant clinical effect.
Breeding.
Iron that is not absorbed is excreted in the feces.
Indication
Treatment of iron deficiency without anemia and iron deficiency anemia.
Iron deficiency and its severity must be confirmed by appropriate laboratory tests.
Contraindication
There is hypersensitivity or intolerance to the active substance or any component of the drug;
excessive iron content in the body (for example, hemochromatosis, hemosiderosis);
disorder of iron excretion mechanisms (lead anemia, sideroachrestic anemia, thalassemia);
anemias not caused by iron deficiency (e.g., hemolytic anemia, megaloblastic anemia caused by vitamin B12 deficiency).
Interaction with other medicinal products and other types of interactions
Studies in rats using tetracycline, aluminum hydroxide, acetylsalicylic acid, sulfasalazine, calcium carbonate, calcium acetate, calcium phosphate in combination with vitamin D3, bromazepam, magnesium aspartate, D-penicillamine, methyldopa, paracetamol, and auranofin did not reveal any interactions with iron(III) hydroxide polymaltose complex.
In vitro studies have shown no interaction of iron(III) hydroxide polymaltose complex with food components such as phytic acid, oxalic acid, tannin, sodium alginate, choline and choline salts, vitamin A, vitamin D3 and vitamin E, soybean oil and soybean flour. The results of the study indicate that iron(III) hydroxide polymaltose complex can be taken with or immediately after meals.
The interaction of polymaltose iron(III) hydroxide complex with tetracycline or aluminum hydroxide was investigated in three clinical studies (cross-over studies involving 22 patients for each study). No significant reduction in tetracycline absorption was observed. The plasma concentration of tetracycline did not fall below the level required for bacteriostatic action. The use of aluminum hydroxide and tetracycline did not reduce the absorption of iron from polymaltose iron(III) hydroxide complex. Therefore, polymaltose iron(III) hydroxide complex can be used simultaneously with tetracyclines, other phenolic compounds and aluminum hydroxide.
The concomitant use of parenteral iron preparations and Maltofer is not recommended, as such use will inhibit the absorption of oral iron preparations. Parenteral iron preparations may be used only when treatment with oral preparations is not appropriate.
The use of the drug does not affect the results of the test for detecting occult blood (sensitive to hemoglobin), so there is no need to stop treatment with the drug.
Application features
Treatment of anemia should always be carried out under the supervision of a physician. If there is no improvement in hematological parameters (an increase in hemoglobin level of approximately 20-30 g/l 3 weeks after the start of treatment), the treatment regimen should be reviewed.
Caution should be exercised in patients receiving repeated blood transfusions, as red blood cells already have a store of iron, and administration of the drug may cause iron overload. Infections and tumors can cause anemia. Oral iron preparations can be taken after the underlying disease has been cured, taking into account the benefit/risk ratio.
When prescribing the drug to patients with diabetes, it should be taken into account that 1 chewable tablet of the drug contains 0.03 bread units.
Iron preparations should be used with caution in patients with the following diseases: leukemia, chronic liver and kidney diseases, inflammatory diseases of the gastrointestinal tract, gastric and duodenal ulcers, intestinal diseases (enteritis, ulcerative colitis, Crohn's disease).
When using iron polymaltose complex, a dark color of feces is possible, but this is of no clinical significance.
Clinical data on the use of Maltofer in such categories of patients as patients with hepatic or renal insufficiency are limited. A careful benefit/risk assessment should be performed in these patients before prescribing Maltofer.
One chewable tablet of Maltofer contains 10 mg of sodium. This amount is equivalent to 0.5% of the WHO recommended maximum daily intake of sodium for adults, which is 2 g.
Use during pregnancy or breastfeeding
Data on use in the first trimester of pregnancy do not indicate an undesirable effect on pregnancy or the health of the fetus or newborn. Data from epidemiological studies are not available. Animal studies have not shown direct or indirect harmful effects on pregnancy, embryonal or fetal development. However, the drug should be used with caution during pregnancy.
Human breast milk contains iron bound to lactoferrin. It is unknown how much iron from iron(III) hydroxide polymaltose complex passes into breast milk.
The use of Maltofer during pregnancy or breastfeeding is recommended only after consulting a doctor. It is recommended to assess the benefit/risk ratio.
Ability to influence reaction speed when driving vehicles or other mechanisms
No relevant studies have been conducted. It is unlikely that Maltofer affects the speed of reactions when driving or operating complex mechanisms.
Method of administration and doses
The dose and duration of treatment with the drug depend on the degree of iron deficiency.
Treatment of iron deficiency without anemia. The recommended dose for adolescents from 12 years of age and adults is 50–100 mg of iron. 1 tablet of Maltofer contains 100 mg of iron. A dose of 50 mg of iron can be obtained by using other dosage forms of Maltofer.
Treatment of iron deficiency anemia. The recommended dose for adolescents aged 12 years and older and adults is 1-3 tablets of Maltofer (100-300 mg of iron).
The daily dose of the drug can be taken at once or divided into several doses. Maltofer chewable tablets should be taken during or immediately after meals, they can be chewed or swallowed whole.
The duration of treatment of iron deficiency anemia until normalization of hemoglobin levels is on average 3-5 months. After that, the drug should be continued in the appropriate dosage for the treatment of iron deficiency without anemia to restore iron stores. The duration of treatment of latent iron deficiency without anemia is 1-2 months.
Children
The drug should be used in children over 12 years of age. Children under 12 years of age are recommended to use Maltofer, syrup, or Maltofer, oral drops.
Overdose
In case of overdose, intoxication or iron accumulation is unlikely due to the low toxicity of iron(III) hydroxide polymaltose complex (for mice and rats, the dose causing death in 50% of animals (LD50) is > 2000 mg iron/kg body weight), saturation of iron absorption is expected. No cases of unintentional overdose with fatal consequences have been reported.
Adverse reactions
Adverse reactions are classified according to the following frequency: very common (> 1/10), common (< 1/10, ≥ 1/100), uncommon (< 1/100, ≥ 1/1000), rare (< 1/1000).
The safety and tolerability of Maltofer were assessed based on a meta-analysis of 24 publications and clinical trial reports involving 1473 patients. The most significant adverse drug reactions reported in these trials were related to four system organ classes (see below).
Faecal discoloration is a well-known adverse reaction to oral iron supplements, but this phenomenon is of no clinical significance and is often underreported. Other common adverse events were gastrointestinal disturbances (nausea, constipation, diarrhoea and abdominal pain).
From the digestive tract.
Very common: change in stool color*.
Common: diarrhea, nausea, abdominal pain (including abdominal pain, dyspepsia, epigastric discomfort, abdominal bloating), constipation.
Uncommon: vomiting (including retching, eructation), tooth enamel discolouration, gastritis.
On the skin and subcutaneous tissue.
Uncommon: pruritus, rash (including rash, macular rash, bullous rash**, urticaria**, erythema**).
From the nervous system.
Uncommon: headache.
Musculoskeletal and connective tissue disorders
Rare: muscle spasms (including involuntary muscle contractions, tremor), myalgia.
*The incidence of stool discoloration in the meta-analysis is lower, although it is a well-known adverse event with oral iron supplements. Therefore, stool discoloration was classified as a very common adverse event.
**Information on these events was obtained from spontaneous post-marketing reports; the frequency is estimated to be < 1/491 (upper limit of the 95% confidence interval).
Expiration date
5 years.
Storage conditions
Store in a place protected from light at a temperature not exceeding 25 ° C. Keep out of the reach of children!
Packaging
10 tablets in a blister; 3 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
Vifor (International) Inc., Switzerland.
Location of the manufacturer and its business address
Rechenstrasse 37, 9014 St.Gallen, Switzerland.
